The Doctrine of Equivalents in Pharmaceutical Actions (Preview)

The doctrine of equivalents plays a critical and often decisive role in pharmaceutical patent litigation, where minor formulation or process changes can mean the difference between infringement and freedom to operate. In this course, Brian D. Coggio and Kelly Allenspach Del Dotto of Fish & Richardson draw on extensive Hatch-Waxman and life sciences litigation experience to unpack how courts apply the doctrine of equivalents in pharmaceutical cases. Beginning with foundational Supreme Court precedent, including Graver Tank and Warner-Jenkinson, the presenters explain the legal rationale behind equivalency and why literal claim scope alone often fails to capture the realities of pharmaceutical innovation.

Coggio and Del Dotto explore how modern courts evaluate equivalence through both the function–way–result and insubstantial differences tests, with particular attention to how these frameworks operate in chemical and biologic contexts. They examine key Federal Circuit decisions involving salt forms, excipients, transdermal patches, formulation steps, and regulatory admissions, while also addressing powerful defenses such as prosecution history estoppel, disclosure-dedication doctrine, prior art ensnarement, and statements made during foreign prosecution. With insight grounded in real Hatch-Waxman disputes and expert-driven evidentiary records, this program highlights what makes or breaks doctrine of equivalents arguments in pharmaceutical patent actions today.

We’re thrilled to announce Lawline’s expansion into Ontario, Canada! This course is approved for CPD credit by the Law Society of Ontario.

Check out the full course: https://www.lawline.com/course/the-do...
Browse our Intellectual Property CLE Course Catalog: https://www.lawline.com/cle/topics/in...
Browse all Ontario-approved courses here: https://www.lawline.com/cle/courses?p...

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